§ 356b. Reports of postmarketing studies

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 title I § 130(a) · 111 Stat. 2296

   Enacted · 21 U.S.C. § 356b

   June 25, 1938, ch. 675, § 506B, as added Pub. L. 105–115, title I, § 130(a), Nov. 21, 1997, 111 Stat. 2331

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 506B, as added Pub. L. 105–115, title I, § 130(a), Nov. 21, 1997, 111 Stat. 2331

   Enacted provision · exact public law section
   (a) In General.— Chapter V, as amended by section 116, is further amended by inserting after section 506A the following: “SEC. 506B. REPORTS OF POSTMARKETING STUDIES. “(a) Submission.— “(1) In general.— A sponsor of a drug that has entered into an agreement with the Secretary to conduct a postmarketing study of a drug shall submit to the Secretary, within 1 year after the approval of such drug and annually thereafter until the study is completed or terminated, a report of the progress of the study or the reasons for the failure of the sponsor to conduct the study. The report shall be submitted in such form as is prescribed by the Secretary in regulations issued by the Secretary. “(2) Agreements prior to effective date.— Any agreement entered into between the Secretary and a sponsor of a drug, prior to the date of enactment of the Food and Drug Administration Modernization Act of 1997, to conduct a postmarketing study of a drug shall be subject to the requirements of paragraph (1). An initial report for such an agreement shall be submitted within 6 months after the date of the issuance of the regulations under paragraph (1). “(b) Consideration of Information as Public Information.— Any information pertaining to a report described in subsection (a) shall be considered to be public information to the extent that the information is necessary— “(1) to identify the sponsor; and “(2) to establish the status of a study described in subsection (a) and the reasons, if any, for any failure to carry out the study. “(c) Status of Studies and Reports.— The Secretary shall Federal Register, publication. annually develop and publish in the Federal Register a report that provides information on the status of the postmarketing studies— “(1) that sponsors have entered into agreements to conduct; and “(2) for which reports have been submitted under subsection (a)(1).”.

2. 2002

   Prescription Drug User Fee Amendments of 2002

   Pub. L. 107–188 title V § 506 · 116 Stat. 594

   Added · 21 U.S.C. § 356b(d); 21 U.S.C. § 356b(e)

   Pub. L. 107–188 added subsecs. (d) and (e)

   Source evidence

   Code amendment note
   Subsecs. (d), (e). Pub. L. 107–188 added subsecs. (d) and (e).

   Enacted provision · exact public law section
   SEC. 506. REPORTS OF POSTMARKETING STUDIES. Section 506B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356b) is amended by adding at the end the following subsections: “(d) Disclosure.— If a sponsor fails to complete an agreed upon study required by this section by its original or otherwise negotiated deadline, the Secretary shall publish a statement on the Internet site of the Food and Drug Administration stating that the study was not completed and, if the reasons for such failure to complete the study were not satisfactory to the Secretary, a statement that such reasons were not satisfactory to the Secretary. “(e) Notification.— With respect to studies of the type required under section 506(b)(2)(A) or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as each of such sections was in effect on the day before the effective date of this subsection, the Secretary may require that a sponsor who, for reasons not satisfactory to the Secretary, fails to complete by its deadline a study under any of such sections of such type for a drug or biological product (including such a study conducted after such effective date) notify practitioners who prescribe such drug or biological product of the failure to complete such study and the questions of clinical benefit, and, where appropriate, questions of safety, that remain unanswered as a result of the failure to complete such study. Nothing in this subsection shall be construed as altering the requirements of the types of studies required under section 506(b)(2)(A) or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as so in effect, or as prohibiting the Secretary from modifying such sections of title 21 of such Code to provide for studies in addition to those of such type.”.

   Effective date note
   Pub. L. 107–188, title V, § 508, June 12, 2002, 116 Stat. 694, provided that: “The amendments made by this subtitle [subtitle A (§§ 501–509) of title V of Pub. L. 107–188, amending this section and sections 379g and 379h of this title] shall take effect October 1, 2002.”

3. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 title IX § 902(c) · 126 Stat. 993

   Substituted · 21 U.S.C. § 356b(e)

   Pub. L. 112–144 substituted “section 356(c)(2)(A) of this title” for “section 356(b)(2)(A) of this title” in two places

   Source evidence

   Code amendment note
   Subsec. (e). Pub. L. 112–144 substituted “section 356(c)(2)(A) of this title” for “section 356(b)(2)(A) of this title” in two places.

   Enacted provision · exact public law section
   (c) Conforming Amendments.— Section 506B(e) (21 U.S.C. 356b) is amended by striking “section 506(b)(2)(A)” each place such term appears and inserting “section 506(c)(2)(A)”.

4. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 div. FF title III § 3210(b) · 136 Stat. 4459

   1. Added · 21 U.S.C. § 356b(a)(2); 21 U.S.C. § 356b(a)(3)

      Pub. L. 117–328 added par. (2)

   2. Redesignated · 21 U.S.C. § 356b(a)(2); 21 U.S.C. § 356b(a)(3)

      Pub. L. 117–328 redesignated former par. (2) as (3)

   Source evidence

   Code amendment note
   Subsec. (a)(2), (3). Pub. L. 117–328 added par. (2) and redesignated former par. (2) as (3).

   Enacted provision · exact public law section
   (b) Reports of Postmarketing Studies.— Section 506B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356b(a)) is amended— (1) by redesignating paragraph (2) as paragraph (3); and (2) by inserting after paragraph (1) the following: “(2) Accelerated approval.— Notwithstanding paragraph (1), a sponsor of a drug approved pursuant to accelerated approval shall submit to the Secretary a report of the progress of any study required under section 506(c), including progress toward enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug and not less frequently than every 180 days thereafter, until the study is completed or terminated. The Secretary Web posting. shall promptly publish on the website of the Food and Drug Administration, in an easily searchable format, the information reported under this paragraph.” .

5 of 5 references resolved to an enrolled provision